NCT02285426

HD+ I-scan Bronchoscopy Vascular Abnormalities Detection Multicenter Study

A Multicenter Study Evaluating the Diagnostic Value for Vascular Abnormalities of High Definition Bronchoscopy When Combined With I-scan Imaging Technology Compared to High Defintion Bronchoscopy Alone

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 134 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Videobronchoscopy is an essential diagnostic procedure for evaluation of the central airways and pivotal for the diagnosis and staging of lung cancer. Further technological improvements have resulted in high definition (HD+) images and advanced image enhancement technique (i-scan). An earlier study (NCT01676012) has indicated that HD+ bronchoscopy in combination with i-scan technology is superior to HD+WL (white light) for detecting endobronchial vascular changes. In this study we aim to correlate these vascular changes to histology and hypothesize that these vascular changes are related to (pre-) malignant changes and that the addition of i-scan is superior to HD+ WL.

Detailed description

Patients will undergo a bronchoscopy with Pentax EB1990i HD-bronchoscope in combination with Pentax EPKi series videoprocessor investigating the entire bronchial tree. Bronchoscopy will be performed by an experienced chest physician under local anaesthesia use and type of sedation following local protocol. Bronchoscopy will be performed in a standardized order using three different imaging modes. The order of the different modes will be randomized to avoid induced scope and / or cough lesion bias. High definition digital videos will be made from all procedures without in screen patient identification, but using a study code. The three imaging modes used in this study are: HD+, HD+ surface enhancement (SE, i-scan1) and HD+ surface enhancement and tone enhancement (TE-c, i-scan2). When sites with abnormal or suspicious vascular patterns are detected the investigator grade these findings using a visual classification scale \[adapted from Herth JTO 2009 \& Zaric Med Oncol 2013\] and change to a regular bronchoscope and take biopsies from each site and a biopsy from a normal secondary carina on the contralateral site as control. Finally any other indicated procedures will be performed at the discretion of the local investigator.

Conditions

• Lungcancer

Interventions

Type	Name	Description
DEVICE	Pentax EB-1990i HD-bronchoscope guided biopsy	3 different types of bronchoscopy image settings will be used investigating the entire bronchial tree. When sites with abnormal or suspicious vascular patterns are detected meeting the criteria of abnormality \[visual scale adapted from Herth 2009 and Zaric 2013\] the investigator will change to a normal bronchoscope and take biopsies from each site and a biopsy from a normal secondary carina on the contralateral site as control.

Timeline

• Start date: 2014-10-20
• Primary completion: 2017-06-05
• Completion: 2017-06-05
• First posted: 2014-11-07
• Last updated: 2018-04-12

Locations

4 sites across 4 countries: Italy, Netherlands, Russia, Spain